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NCT02243592

Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.

Official title: Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

170

Start Date

2014-09-24

Completion Date

2026-04-02

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Malignant Neoplasm

Interventions

OTHER

Laboratory Biomarker Analysis

Undergo sequencing and SNP analysis

Inclusion Criteria: * Documented exceptional response, defined as patients meeting the following criteria: * Complete response to a regimen in which complete response is expected in \< 10% of similarly treated patients * Partial response (PR) \> 6 months in a regimen in which PRs \> 6 months are expected in \< 10% of patients with similar disease treated with same or similar regimen * Complete response (CR) or PR of unusual duration, such that the internal review committee considers it to be an exceptional response; examples below: * PR of duration \> 3 x the median expected PR duration (in cases where PR is expected in \> 10% of patients with the same disease treated with the same regimen) * CR or duration \> 3 x the median expected CR duration (in cases where CR may be seen in \> 10% of patients with same disease treated with same regimen) * The observed duration of CR (or PR) is longer than expected for 90% of patients with same disease treated with same regimen * Note: it is not required that the patient be enrolled on a clinical trial when the exceptional response was observed * Reports of radiologic scans or other evidence documenting response will be submitted for review; cases where response is not assessable (e.g. adjuvant treatment) will not be eligible because the outcome can not be attributed to a specific treatment * Treatment history must be available, for prior treatment and for the drug to which the exceptional response occurred * Patient must meet consent criteria; this requires: (i) current exceptional responder (ER) consent by a living participant not lost to follow-up, (ii) prior consent for future research by a participant not known to be deceased, but lost to follow-up, or (iii) if patient is deceased and did not decline to participate in research at the time of tissue removal for any tissue that would be used in this study, then no consent is required * Tumor sample available that meets study requirements * Required tumor samples MUST exist and be able to be submitted; investigators wishing to submit samples must not have made agreements that would prohibit the free use of data from such samples; the National Cancer Institute (NCI) will provide investigators with a letter for the collaborator amending their existing agreement to allow for the case to be submitted * Tumor tissue from prior to administration of the drug to which the exceptional response occurred is required; ideally this sample will have been collected just prior to treatment, but other prior tissue will be considered; tissue may be fresh frozen or formalin-fixed paraffin embedded * Tumor tissue amount must be at least a core biopsy, and meet minimum specimen requirements * Encouraged: normal tissue sample: (optional): blood or other specimen source for germline sequencing * The tumor samples and clinical data submitted to the Exceptional Responders Database in database in Genotypes and Phenotypes (dbGaP) will need to have appropriate agreements in place to allow for the submission; the Exceptional Responders Database can accept clinical data and samples from cases enrolled on a Cancer Therapy Evaluation Program (CTEP) sponsored clinical trial and cases that were not enrolled on any clinical trial; if the response occurred on a trial that was not CTEP-sponsored, there are existing agreements between the submitting site and the pharmaceutical company; if existing agreements do not allow for the submission of sample and clinical data, the NCI will provide the investigators with a letter that allows the tissue to be used for the exceptional responders study if signed by the appropriate collaborator; the letter modifies the existing agreement to include the CTEP Intellectual Property (IP) Option language that would allow the case to be submitted to the Exceptional Responders Database; if the existing agreement cannot be modified and the letter cannot be signed, the proposed case will not be accepted; Note: as stated above, the patient does not need to have been enrolled on a clinical trial to be eligible for the exceptional responders study Exclusion Criteria: * Patient's response did not meet criteria for an exceptional response * Patient's treatment regimen is expected to lead to CR or durable PR in \> 10% of patients * Patient's duration of response is not \> 3 x expected median length of response * Response not evaluable or not able to be attributed to systemic treatment (e.g. adjuvant treatment) * Patient refused consent for use of tissue for research activities included in the exceptional responders study * Tumor sample from prior to the exceptional response is not available, or does not meet quality metrics

Locations (73)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Greenwich Hospital

Greenwich, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

South Georgia Medical Center/Pearlman Cancer Center

Valdosta, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Presence Resurrection Medical Center

Chicago, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

York Hospital

York Village, Maine, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

NCI - Center for Cancer Research

Bethesda, Maryland, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

UP Health System Hematology Oncology Marquette

Marquette, Michigan, United States

UP Health System Marquette

Marquette, Michigan, United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

University of Rochester

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Kaiser Permanente Northwest

Portland, Oregon, United States

Reading Hospital McGlinn Cancer Institute at Phoenixville

Phoenixville, Pennsylvania, United States

Chester County Hospital

West Chester, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Wellmont Holston Valley Hospital and Medical Center

Kingsport, Tennessee, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

WVUH-Berkely Medical Center

Martinsburg, West Virginia, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Clinical Research Directory

Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (73)